Recall Z-0602-2012 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number: 6705995, 6705996, 6705997/ Part number: 6705998, 67059999, 6706000. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in cli
| Date | Jan 11, 2012 (initiated Oct 13, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer. |
| Root cause | Nonconforming Material/Component |
| Action | Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to contact Beckman Coulter Service at (800) 526-7694 if they were experiencing failures. Customers not experiencing failures, but their system may have the suspect chips, were told they would be contacted by Beckman Coulter Service to correct their problem. Customers were also instructed to complete and return an enclosed Response Form. |
| Quantity | 1 unit total |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922704 | COULTER MAXM W/ AUTOLOADER Coulter Electronics, Inc., Jul 27, 1992 |